The International Journal of Risk and Safety in Medicine is concerned with rendering the practice of medicine as safe as it can be; that involves promoting the highest possible quality of care, but also examining how those risks which are inevitable can be contained and managed.

This is not exclusively a drugs journal. Recently it was decided to include in the subtitle of the journal three items to better indicate the scope of the journal, i.e. patient safety, pharmacovigilance and liability and the Editorial Board was adjusted accordingly. For each of these sections an Associate Editor was invited. We especially want to emphasize patient safety. Our journal wants to publish high quality interdisciplinary papers related to patient safety, not the ones for domain specialists. For quite some time we have also been devoting some pages in every issue to what we simply call WHO news. This affinity with WHO underlines both the International character of the journal and the subject matter we want to cover. Basic research, reports of clinical experience and overviews will all be considered for publication, but since major reviews of the literature are often written at the invitation of the Editorial Board it is generally advisable to consult with the Editor in advance. Submission of news items will be appreciated, as will be the contribution of letters on topics which have been dealt with in the journal.

Abstract: Mothers of boys with hypospadias and control mothers were interviewed in eight malformation monitoring programs around the world. Hormone therapy was used quite frequently in five but rarely in three of the programs. The odds ratio for hypospadias after hormone therapy during pregnancy was 2.8 (95% confidence limits 1.2, 6.9) but there was no correlation between the timing of hormone therapy and the location of the urethral orifice, nor between the severity of the malformation and hormone therapy. Programs with the highest hormone exposure rate showed the lowest odds ratio for pregnancy bleeding, the most common reason for hormone therapy.…These latter findings cast doubts on the causal association between hormone therapy and isolated hypospadias. Alternative explanations are recall or interviewer bias or unidentified confounders.
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Abstract: A study was conducted in a cohort of New Zealand births on the prevalence of anencephalus and spina bifida in relation to various chemical elements in the drinking water. Cases were ascertained from national infant mortality and late fetal death records, and public hospital records and consisted of still and live births (of 28 or more weeks gestation) during 1978–1982 with anencephalus or spina bifida diagnosed either at birth or during the first year of life. The 460 cases were matched with their official birth registration records and a sample of 5000 control births was randomly selected from all non-NTD…still- and livebirths. Drinking water data were obtained from a national surveillance program. Iron was the only water element to be included in the stepwise multiple logistic regression model of anencephalus prevalence, and magnesium, sulphate, and nitrate nitrogen were retained in the spina bifida model. This indicates a statistically significant association between these elements and the respective outcome. The results for iron and nitrate nitrogen were contrary to findings from previous studies. Despite the methodological problems associated with such ecological studies, there are indications that the constituents of a water supply may have an impact on the risk of NTDs.
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Abstract: A collaborative study with 8 Teratology Information Centres was undertaken to collect data on anorectic exposures (amfepramone, clobenzorex, dexfenfluramine, fenfluramine, fenproporex) during pregnancy. Two hundred and ninety seven prospective enquiries were analysed of which 285 exposures occurred during the first trimester. Outcome of pregnancy was known for 164 of these cases. Voluntary or medical abortion was decided in 30 cases (18%), spontaneous abortion occurred in 14 cases (8.5%), extrauterine pregnancy in 1 patient and fetal death following drug abuse in another. A normal infant was delivered in 111 cases (68%). Low birthweight was identified in 1 case and neonatal complications…in 2 cases. Various congenital abnormalities were noted in 4 cases (1 minor and 3 major), with no clear cause-effect relationship (2 amfepramone, 1 fenproporex and 1 dexfenfluramine). Although the number of exposed pregnancies in this cohort was too small to rule out any increase in teratogenic effects of anorectics, the results of this survey suggest that the risk for malformations, especially for dexfenfluramine is probably not greater than the 2–3% risk for pregnancies in the general population. Morover, these results provide substantial information for future enquiries about exposure to such medication during organogenesis.
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Abstract: In Norway a series of complementary systems have been established for the reporting of injuries and accidents occurring during the course of hospital treatment. Alongside a number of obligations to report such matters to an external body, depending on the nature of the event, many hospitals have created their own internal reporting systems. The latter were originally conceived largely as a defence mechanism for the event that the patient should bring legal action against the hospital, but like the various external reporting mechanisms these systems are today increasingly viewed as an instrument for quality assurance, enabling the hospital to benefit…from experience. Although many of the elements are in place, including an increasingly clear view on patients' rights to information, concern has to be expressed at the multiplicity of mechanisms which now exists, some simplification is called for. There is also a need to ensure much greater compliance with these systems if they are to serve their purpose.
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